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Effectiveness of a Digital Activity Platform for Informal and Formal Caregivers in Long-Term Care Facilities (EngageLTCdigit)

2026년 8월 18일 업데이트: Janine-Julia Hörzig, University of Applied Sciences for Health Professions Upper Austria

Effectiveness Research on a Digital Engagement Platform in Long- Term Care on Informal and Formal Caregivers [Short Title: EngageLTCdigital]

The purpose of this study is to determine whether a digital engagement platform can support caregivers working in long-term care facilities. The main question is:

Does the use of a digital engagement platform improve person-centred care for older adults living in long-term care facilities? The study includes formal caregivers (such as nursing staff) and informal caregivers (such as volunteers, family members, and civilian service participants) who provide care and support to older adults in long-term care facilities.

One group of participants will use the digital engagement platform as part of their daily care activities. A comparison group will continue with usual care without access to the platform. Participants will take part in the study for 12 weeks and complete questionnaires at several time points. In addition, platform usage data will be collected.

In addition to person-centred care, the study will examine:

  • Whether the platform improves caregivers' cultural competence.
  • Whether the platform supports the collection and documentation of residents' life history information.
  • How often and how long the platform is used by caregivers.
  • Caregivers' experiences with and satisfaction with the platform. The findings may help improve digital tools that support caregivers and enhance the quality of care for older adults in long-term care settings.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Background Population aging and the increasing number of older people with cognitive and physical impairments present major challenges for long-term care facilities. At the same time, shortages of nursing and care staff, as well as a decline in informal support, contribute to increasing demands on caregivers. In this context, innovative approaches are needed to support caregivers and promote high-quality person-centred care.Person-centred care focuses on the individual needs, preferences, abilities, and life experiences of residents. Digital technologies may support caregivers in planning and delivering individualized and meaningful activities while enhancing residents' social participation.

Study Objectives The primary objective of this study is to investigate the effects of using the digital engagement platform on person-centred care. In addition, the study will examine caregivers' cultural competence, the collection of residents' biographical information, the frequency and duration of platform use, and users' experiences with the platform. Adverse events occurring during the study period will also be documented.

Intervention This study evaluates the effectiveness of the digital engagement platform "PflegeZeit" in residential long-term care facilities. The platform is used on tablets or other digital devices and provides individualized engagement activities. The intervention is based on three core components: the integration of biographical information and reminiscence, cognitive stimulation, and physical activation. By combining these components, the platform aims to support caregivers in implementing individualized and person-centred engagement activities in everyday care practice.

Control Group The control group will not receive access to the digital engagement platform and will continue routine care practices within their respective long-term care facilities. No additional digital support tools will be provided as part of the study.

Study Population The study targets both formal caregivers (e.g., nursing and care staff) and informal caregivers (e.g., family members, volunteers, or civilian service participants) who provide care and support to residents in residential long-term care facilities.

Defined inclusion and exclusion criteria will be applied to ensure that participants represent the intended target population. Detailed eligibility criteria are provided in the corresponding section of the study registration.

Study Design The study is designed as a multicentre, open-label, quasi-experimental pre-post study with a control group.

Participating long-term care facilities will be assigned to either the intervention group or the control group prior to study initiation. Facilities in the intervention group will implement the digital engagement platform as part of routine care, whereas facilities in the control group will continue providing usual care without the platform. Participants will be observed over a period of 12 weeks. Data collection will take place at four time points: baseline and after 4, 8, and 12 weeks.

Sample Size and Recruitment Participating caregivers will be recruited from four to eight long-term care facilities. The sample size is based on the primary outcome, the group-by-time interaction in the Person-Centred Practice Inventory for Staff (PCPI-S), and was determined using an a priori sample size calculation conducted with G*Power 3.1. The calculation indicated a required sample size of 36 participants. To account for an anticipated dropout rate of up to 15%, a target sample size of 42 caregivers will be recruited. Of these, 21 participants will be allocated to the intervention group and 21 participants to the control group.

Statistical Analysis Data analysis will be conducted according to a predefined statistical analysis plan. Descriptive statistical methods will be used to characterize the study population and study variables. Changes over time and differences between the intervention and control groups will be evaluated using linear mixed-effects models. These analyses will account for both repeated measurements and the clustered structure of the data at the facility level.

Potential Benefits and Risks The use of digital health applications in long-term care has the potential to support caregivers in the delivery of person-centred care. Previous research suggests that digital interventions may positively influence communication, caregivers' job satisfaction, and the social participation of residents. This study aims to provide further evidence regarding the potential benefits of a digital engagement platform in residential long-term care settings.

No specific risks or disadvantages associated with participation in the study or the use of the digital engagement platform are known for caregivers. The platform is used within routine care activities. Any additional burden is limited to the time required for platform use and participation in study-related data collection. Adverse events will be systematically monitored and documented throughout the study.

Expected Contribution The findings of this study are expected to contribute to the evidence base for digital support interventions in long-term care. The results may help identify effective strategies to support caregivers, strengthen person-centred care, and further develop the quality of care for residents in residential long-term care facilities

연구 유형

중재적

등록 (추정된)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Upper Austria
      • Bad Hall, Upper Austria, 오스트리아, 4540
        • 모병
        • Seniorenwohnhaus Schloss Hall - Caritas OÖ
        • 연락하다:
      • Engelhartszell, Upper Austria, 오스트리아, 4090
      • Kremsmünster, Upper Austria, 오스트리아, 4550
      • Linz, Upper Austria, 오스트리아, 4020
        • 모병
        • Seniorenwohnhaus St. Anna - Caritas OÖ
        • 연락하다:
      • Micheldorf in Oberösterreich, Upper Austria, 오스트리아, 4563
        • 모병
        • Bezirksalten- und Pflegeheim Micheldorf
        • 연락하다:
      • Steyr, Upper Austria, 오스트리아, 4400
        • 모병
        • Alten- und Pflegeheim Ennsleite
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • Formal or informal caregivers of nursing home residents
  • Setting: Inpatient long-term care facilities in Upper Austria
  • Minimum age: 18 years
  • Willingness to use a digital app
  • Sufficient knowledge of German (at least level B2)

Exclusion Criteria:

  • No care for nursing home residents
  • Work outside inpatient long-term care facilities (e.g. mobile care, hospital, rehabilitation, assisted living)
  • Age: under 18 year
  • No willingness to use the digital engagement platform
  • Insufficient knowledge of German (below B2 level)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm A: Intervention Group (Digital Activation Platform)
The digital activation platform "PflegeZeit" is a tablet-based application used by formal and informal caregivers in long-term care facilities to support individualized engagement activities for residents. The platform combines biographical engagement and reminiscence, cognitive activation, and physical activation. It is used as part of routine care during the 12-week study period. Frequency and duration of use are determined according to individual care needs and routine care practices. Platform usage data are automatically recorded.
The intervention is based on three core pillars: (1) promoting familiarity and biographical engagement through content reflecting residents' life context (e.g., traditions, music, and image-based materials); (2) supporting cognitive activation through individually adaptable memory and problem-solving tasks as well as sensory exercises; and (3) enhancing physical and psychosocial resources through movement based activities, including chair-based exercises, group activities, and guided physical exercises.
간섭 없음: Arm B: Control Group (Usual Care)
The control group will receive standard care, consisting of routine care services without access to the digital activation platform. Care providers will continue their usual activities and utilize the programs available within the facilities (digital or print-based). They will be involved in shaping the care process of the residents and will document all nursing interventions in accordance with the legal requirements of the Health and Nursing Care Act (GuKG), including nursing assessment, nursing diagnoses, care planning, and nursing interventions.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To examine the effects of a digital engagement platform on person-centred care.
기간: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
Mean change in indicators of person-centred care associated with the use of the digital engagement platform in nursing homes, estimated with the instrument Person-Centred Practice Inventory - Staff (PCPI-S).
Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

2차 결과 측정

결과 측정
측정값 설명
기간
To examine the effects of the digital engagement platform on caregivers' cultural competence.
기간: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

Mean change in caregivers' cultural competence associated with the use of the digital engagement platform for nursing home residents estimated with CCA-A German Version.

CCA-A German Version: is a questionnaire that assesses the cultural competences of the caregivers.

Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
To examine the effects of the digital engagement platform on caregivers' adherence to biographical information entry.
기간: Measured at Baseline (Day 1) and Visit 3 at Month 3 (Day 84).
Mean change in caregivers' adherence to biographical information entry within the database of the nursing home, estimated using predefined questionnaire on number of words in the database.
Measured at Baseline (Day 1) and Visit 3 at Month 3 (Day 84).
To examine the effects of the digital engagement platform on duration and intensity of use by caregivers.
기간: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
Mean change in duration and frequency of use of the digital engagement platform by caregivers, estimated using system-generated usage metrics.
Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
To examine the effects of the digital engagement platform on caregivers' user experience.
기간: Measured at Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
Mean change in caregivers' user experience with the digital engagement platform, estimated with the UEQ-S
Measured at Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
A standardized form will be used to document adverse events (AEs) occurring during the study procedures.
기간: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
Number of adverse events estimated via a AE form sheet.
Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 연구 의자: FH-Prof. Aff. Hon. Asst. Prof. Dr. Bernhard h Schwartz, BSc MSc, University of Applied Sciences for Health Professions Upper Austria

간행물 및 유용한 링크

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 3월 1일

연구 완료 (추정된)

2027년 4월 1일

연구 등록 날짜

최초 제출

2026년 8월 10일

QC 기준을 충족하는 최초 제출

2026년 8월 18일

처음 게시됨 (실제)

2026년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 18일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • P-2025-022

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individuals data will not be shared, because of the European General Data protection regulation. Group-wise results might be shared.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .